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PET/CT in the Management of Patients With Early Stage Endometrial Cancer

Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03570866
Acronym
ENCA-1
Enrollment
40
Registered
2018-06-27
Start date
2022-05-01
Completion date
2024-05-01
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrium Cancer

Keywords

Endometrial cancer, Positron emission tomography

Brief summary

Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion \> 50% or grade 3 endometrioid lesion with \< 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion \> 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.

Interventions

Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.

PROCEDURESurgical treatment

Surgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy.

Sponsors

Universita di Verona
CollaboratorOTHER
Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Women with diagnosis of early stage intermediate and high-risk endometrial cancer.

Exclusion criteria

* Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of positron emission tomography and computed tomographyThrough study completion, an average of 5 yearComparing Positron emission tomography and computed tomography results with Histopathological findings served as the standard of reference. True positive, True negative, False positive, False negative. Sensitivity, Specificity, Negative predictive value, Positive predictive value.

Secondary

MeasureTime frameDescription
Progression free survivalThrough study completion, an average of 5 yearEvents of disease recurrence in the study group
Overall survivalThrough study completion, an average of 5 yearEvents of death in the study group

Contacts

Primary ContactAntonio Simone Laganà, M.D.
antoniosimone.lagana@asst-settelaghi.it‭+39 329 6279579‬
Backup ContactSimone Garzon, M.D.
simone.garzon@univr.it+393470782287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026